New multimodal intervention to reduce irritable bowel syndrome (IBS) severity symptoms—Pilot study with a 12 month follow-up

Introduction Irritable bowel syndrome (IBS) is characterized by patients’ high level of suffering. Up to 60% of patients with IBS have symptoms of anxiety or depression and only little attention has been paid to their specific requirements. Anthroposophical multimodal therapy (AMT) has been shown to significantly improve health-related quality of life of patients with high symptomatic burden. Objective The aim of this pilot study was to find out whether AMT meets the needs of IBS patients and the interactions of AMT with IBS, depression and anxiety Methods Patients with diagnosed IBS were included in a feasibility study and received 12 sessions of AMT over 8 weeks (drks.de, DRKS00016890). The primary endpoint was the change of the IBS severity score (IBS-SSS) and changes were calculated by linear mixed effects analyses. The secondary endpoints were changes of self-reported PHQ-9 and GAD-7 for mental comorbidity as well as self-valued effectiveness and satisfaction of AMT. Results Thirty-six patients, 89% female, were included in the study. AMT was successfully applied to IBS patients (-45 points in the IBS-SSS, p < .05). AMT had a large positive effect (-84 points in IBS-SSS, p < .003) on patients without anxiety or depression. Over time, patients with higher anxiety scores worsened with regard to their IBS compared to patients with depression and without mental comorbidity. The AMT effect was maintained at a 12 month follow up and both mentally affected and unaffected patients, had even lower IBS severity than shortly after AMT. AMT modules were rated by IBS patients as very effective. Conclusion Our findings suggest that an 8-week program of AMT improves the severity of IBS with an ongoing effect at a 12 month follow-up. Especially for patients without psychological comorbidities, AMT is very successful. Future IBS therapies should incorporate a modified multimodal concept with stronger psychological therapy modules in parallel for patients with depression and anxiety.


Introduction and research question
The following is an overview of the components and procedures of the planned intervention study on irritable bowel syndrome at the Havelhöhe Community Hospital in cooperation with the Max Lüscher Foundation (Switzerland) and the Steinbeis University of Applied Sciences Berlin.
The aim is to investigate the effects (in particular the improvement of physical and mental wellbeing) of an integrative short-term therapy approach with multimodal therapy elements based on anthroposophic medicine in the treatment of irritable bowel syndrome. For this purpose, different therapy modules and their effects on a cohort of irritable bowel patients will be analysed (1st study hypothesis: therapy effect versus waiting group).
Various survey instruments will be used within the study (see point 4.3.). It is to be investigated whether and which schema disorders predispose the irritable bowel syndrome. Here, the Lüscher colour test as a non-verbal personality test is to be compared with validated psychometric tests (2nd study hypothesis: participant collective shows specific uniform patterns / 3rd study hypothesis: survey differences between non-verbal and verbal survey instruments).

Presentation of the clinical picture of irritable bowel syndrome
In gastroenterology, irritable bowel syndrome is one of the functional gastrointestinal diseases that are often characterised by typical constellations of symptoms. The following typical symptoms can be present in patients together, individually or in any combination.
Combinations of complaints and symptoms are quite common. In addition to the typical symptoms, there may be -mental and physical exhaustion as well as -other psychological symptoms (ibid.).

Epidemiology
The prevalence and incidence of IBS patients depend on the definitions used (Manning, Kruis, Rome I, II, III). According to current studies, the prevalence ranges from 2.5 to 25% (Manning), 5.5 to 13.6% (Rome I) and 2.5 to 19.1% (Rome II). These show a higher prevalence and variability according to Manning compared to Rome I and II criteria. Here, the number of Manning criteria used influences the prevalence from 2.5 -37%; when 3 Manning criteria are used, the prevalence is about 10%. The pooled prevalence is 7% (Leyer et al., 2011).

Course of the disease
Irritable bowel syndrome regresses spontaneously in some patients, but is often chronic. There is no increased co-prevalence with other serious diseases of the gastrointestinal tract, but certainly with serious other diseases, such as depression, anxiety disorders, somatoform disorders and rigid personality accentuation.
The prognosis of IBS depends on the length of the medical history. Patients with a long medical history are less likely to improve. In this case, permanent life stress is relevant to the prognosis. Irritable bowel syndrome is not associated with the development of other gastrointestinal or other serious diseases and does not have an increased mortality. Irritable bowel patients have a higher risk of surgery (hysterectomy, cholecystectomy) than non-irritable bowel patients.

Diagnostics
According to the currently valid German medical guidelines, irritable bowel syndrome exists if all of the following three conditions are fulfilled. 1: 1. there are chronic complaints, i.e. lasting longer than 3 months (e.g. abdominal pain, flatulence), which are referred to the intestine by the patient and doctor and are usually accompanied by changes in bowel movements. 2. the complaints should justify the patient seeking help and/or worrying about it, and be so severe that the quality of life is relevantly impaired by it. 3. it is a prerequisite that there are no changes characteristic of other clinical pictures which could probably be responsible for these symptoms.

Presentation of the short-term therapy approach
Therapy elements / modules

Psychoeducation
Psychoeducation serves to inform patients about the disease and its course as well as a healing way of dealing with it. In particular, the following goals are pursued through the structured communication of information: -Promotion of the understanding of the disease and the self-responsible handling of it -Support in coping with the disease -Reduction of fears, feelings of guilt and shame.

Artistic therapies (sculpting, painting)
Within the art therapy, tried and tested methods are used by experienced therapists from the Havelhöhe Clinic. As "non-verbal psychotherapy", these are particularly effective on the psychological level of the patients and promote introspective self-regulation processes and are also intended to serve as an exercise of will in the study setting.

Movement therapy (eurythmy therapy)
Eurythmy therapy as a special movement therapy is intended to mediate the patient's balance between tension and relaxation and to be activated by rhythmic exercises with the body. Within movement therapy, patients learn to better perceive and evaluate their own bodily processes and to enter into their own process of change.

External application
Within this module, different wraps and their indications are introduced and tried out, which the patients can then apply on their own, easily and inexpensively, if necessary.

Healing Imagination
In the context of healing imagination, an evidence-based, specially developed intestinal hypnosis is used, which is intended to give the patients peace and relaxation and relief from their complaints.

Nutritional counselling
This is to advise patients on specifics of their diet and eating habits. Individual questions, food intolerances and allergies should also be addressed.

Cognitive training group
Within the cognitive training group, the contents of the specific treatment day are reflected on, among other things, with the help of structuring work materials. This is to ensure that the patients deal with the therapy elements in the long term and can also apply individual elements in everyday life.

Target group/ Requirements
Requirements Participants who meet the diagnostic criteria according to 2.3.

Group size
A group size of 12-15 participants is planned. This means that with 4 planned groups, a total number of 60 participants is planned.

Contra-indications
Suicidality, psychotic experience, other study participation Recruitment of participants Press, waiting list, Internet, GPs, MVZs

Treatment period -weekly schedule
• Within the first four weeks, two treatment days per week and within the second four weeks, one treatment day per week (12 treatment days in total). • -2 groups per week: Mon / Wed ; Tue / Thu (16.30 to 18.30 hrs and 19.00 to 21.00 hrs respectively)

Therapy manual / patient literature / worksheets
In order to ensure an equivalent, standardised implementation of the individual therapy elements, the following therapy manuals are to be created: -Psychoeducation -External application -Healing imagination -Cognitive training group The contents of the mentioned therapy elements will be planned for the study and documented within the manuals. Furthermore, the patients will receive information material in the form of flyers at the beginning of the therapy on the following modules: -Psychoeducation -External application Within the cognitive training group, work materials will be used to incorporate exercise elements into the therapy. For each of the 12 therapy days, a worksheet is designed to reflect the contents of the day. In addition, patients are given a booklet for self-documentation during and after the 12 days of treatment.

Project implementation
The project is to be carried out by an assembled project team. The following persons are planned for the project team:

Timetable and study design
With a planned number of 4 groups and a duration of 8 weeks per group, this results in a pure survey period of 12 weeks (from mid-January 2018 to mid-April 2018). The two waiting groups start the intervention from the 5th week. Patients will be randomly assigned to the groups. Treatment groups 1 and 2 will receive treatment on Mondays and Wednesdays, while waiting groups 3 and 4 will receive treatment on Tuesdays and Thursdays, thus guaranteeing that treatment and waiting groups cannot meet.

Instruments / Test diagnostics
Three survey dates are planned within the framework of a pretest-posttest design with a final follow-up. This is to ensure that differences between pre-and posttest measurements can be collected. A follow-up survey after 12 months will examine the long-term effect of the intervention. Furthermore, two survey dates are planned as part of the comparison between treatment and waiting list group. Care should be taken during the survey to ensure that the duration of the tests is reasonable. For this reason, all questionnaires will be sent to the patients